[ Price : $8.95]
FDA releases the 17-page form FDA-483 following a May inspection at Indias Strides Pharma Science drug manufacturing facility in B...[ Price : $8.95]
In its report on FY 2024 approvals of medical devices for pediatric uses, FDA says that 19 of the 56 device approvals that year we...[ Price : $8.95]
FDA releases the form FDA-483 with three observations from an inspection at the Novel Laboratories (Lupin) drug manufacturing faci...[ Price : $8.95]
NOTUS reports that FDA will reorganize on 10/1 to a shared services model in which administrative functions are centralized, and i...[ Price : $8.95]
A BioProcess International column says drug companies should design a controlled evidence ecosystem that can demonstrate to FDA in...[ Price : $8.95]
Novo Nordisk intensifies pressure against Eli Lilly under a motion seeking a preliminary injunction to stop Eli Lilly's misleading...[ Price : $8.95]
CBER recently used a virtual town hall to urge developers of cell and gene therapies to take advantage of early engagements with t...[ Price : $8.95]
An FDA final guidance encourages sponsors of oncology clinical trials to broaden eligibility criteria by including more patients w...